Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.

Patient procedural success [ Time Frame: Time Frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first. ] [ Designated as safety issue: No ]

Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.

Surgical and hospitalization factors [ Time Frame: Time Frame: Day of procedure through discharge ] [ Designated as safety issue: No ]

Cross-clamp time (minutes/hours), Cardiopulmonary bypass time (minutes/hours) and the length of time (minutes/hours) the patient spends in the intensive care unit (ICU) will be recorded.

Other Outcome Measures:

Quality of life survey at one year compared to baseline [ Time Frame: Time Frame: Baseline and one year follow-up ] [ Designated as safety issue: No ]

The following outcome for additional evaluation will be the change in Short Form 12 version 1 (SF-12v2) Quality of Life questionnaire from Baseline to 1 year.

All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.

Device: EDWARDS INTUITY valve

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Detailed Description:

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of five years.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

Male or female, age 18 years or older

Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replace-ment as indicated in the preoperative evaluation

Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery

Provide written informed consent

Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Exclusion Criteria:

Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:

Pure aortic insufficiency

Requires emergency surgery

Previous aortic valve replacement

Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ

Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial

_____

Intra-operative Exclusion Criteria

Anatomic variances which contraindicate implant of the trial valve, such as:

anomalous coronary arteries

annular deformation or extensive calcification of the annulus or aortic root which cannot be removed

significant calcium on the anterior mitral leaflet

pronounced septal calcification

position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow

Available devices are not suitably sized for the subject's annulus

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700439